Production of sterile active pharmaceutical ingredients

Abstract

The invention refers to a process for preparing sterile active pharmaceutical ingredients (APIs) useful in the preparation of sterile product for ophthalmic use. The process comprises the gamma-ray sterilization treatment of the APIs powder in a protective atmosphere.

The invention claimed is: 
     
       1. A process for preparation of a sterile Brinzolamide, the process comprising:
 placing a bulk powder of Brinzolamide inside a bag made of polyethylene; 
 creating a protective atmosphere that replaces ambient air in the bag made of polyethylene; 
 sealing the bag made of polyethylene; 
 placing the sealed bag made of polyethylene inside a bag made of oxygen-and-humidity-proof high-barrier material, wherein the high barrier material is polylaminated aluminium or metallized foil coupled with polyester and polypropylene or polyethylene; 
 creating a protective atmosphere that replaces ambient air in the bag made of oxygen-and-humidity-proof high-barrier material; 
 wherein the protective atmosphere that replaces ambient air in the bag made of polyethylene and in the bag made of oxygen-and-humidity-proof high-barrier material is selected from vacuum, argon, nitrogen, and helium; 
 sealing the bag made of oxygen-and-humidity-proof high-barrier material; and 
 performing terminal gamma-ray sterilization treatment on the bulk powder of Brinzolamide. 
 
     
     
       2. The process according to  claim 1 , wherein the gamma-ray sterilization treatment is carried out with a radiation of 25 kGy. 
     
     
       3. The process according to  claim 1 , wherein the gamma-ray sterilization treatment is carried out on the Brinzolamide powder packed under vacuum. 
     
     
       4. The process according to  claim 1 , wherein the gamma-ray sterilization treatment is carried out on the Brinzolamide powder packed in nitrogen or helium atmosphere. 
     
     
       5. The process according to  claim 1 , wherein the gamma-ray sterilization treatment is carried out at room temperature or below zero up to −78° C. 
     
     
       6. The process according to  claim 2 , wherein the gamma-ray, sterilization treatment is carried out at −78° C., with a radiation of 25 kGy and on the Brinzolamide powder packed in helium atmosphere.